scholarly journals Pediatric Tuina For Functional Constipation In Children: Study Protocol For A Randomized Controlled Trail

2021 ◽  
Author(s):  
Xinghe Zhang ◽  
Luan Hu ◽  
Li Li ◽  
Yuanwang Wang ◽  
Can Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Period ◽  
Functional Constipation ◽  
Gastrointestinal Disorder ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Pediatric Tuina ◽  
Randomized Controlled ◽  
Bowel Movements

Abstract Background: Functional constipation (FC) is a common functional gastrointestinal disorder (FGID), which brings many negative impacts to the children’s daily life. Pediatric Tuina has been proved to be a potential therapy for functional constipation (FC). However, the evidence for its effectiveness and safety is insufficient due to the lack of high-quality study. This study aims to evaluate the efficacy and safety of pediatric Tuina for children with FC.Methods/design: This study is a randomized, controlled, multicentre, clinical trial. We will include 176 children with FC from five hospitals. The participants will be randomly allocated into two groups: the pediatric Tuina group and the Medilac-Vita group. This study will include a 1-week actual treatment period and a 2-week follow-up period. Primary outcomes are weekly spontaneous bowel movements (SBMs), weekly complete spontaneous bowel movements (CSBMs). The secondary outcomes are effective rate, stool form, distress sensation, and glycerine enema rate. The assessment will be performed each week. Adverse event will be monitored in treatment period and follow-up period.Discussion: This study is designed to evaluate the efficacy and safety of pediatric Tuina for children with FC, and we hypothesize that pediatric Tuina is more effective than probiotics. It will provide reliable evidence and support for the treatment of FC by pediatric Tuina.Trail registration: This protocol was registered in Chinese Clinical Trial Registry (ChiCTR2100046485).

Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial

2018 ◽  
Vol 46 (6) ◽  
pp. 1343-1351 ◽  
Author(s):  
Mats Brittberg ◽  
David Recker ◽  
John Ilgenfritz ◽  
Daniel B.F. Saris ◽  
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Extension Study ◽  
Cartilage Defects ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
And Function ◽  
Mri Evaluation ◽  
Cultured Chondrocytes

Background: Matrix-based cell therapy improves surgical handling, increases patient comfort, and allows for expanded indications with better reliability within the knee joint. Five-year efficacy and safety of autologous cultured chondrocytes on porcine collagen membrane (MACI) versus microfracture for treating cartilage defects have not yet been reported from any randomized controlled clinical trial. Purpose: To examine the clinical efficacy and safety results at 5 years after treatment with MACI and compare these with the efficacy and safety of microfracture treatment for symptomatic cartilage defects of the knee. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This article describes the 5-year follow-up of the SUMMIT (Superiority of MACI Implant Versus Microfracture Treatment) clinical trial conducted at 14 study sites in Europe. All 144 patients who participated in SUMMIT were eligible to enroll; analyses of the 5-year data were performed with data from patients who signed informed consent and continued in the Extension study. Results: Of the 144 patients randomized in the SUMMIT trial, 128 signed informed consent and continued observation in the Extension study: 65 MACI (90.3%) and 63 microfracture (87.5%). The improvements in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain and Function domains previously described were maintained over the 5-year follow-up. Five years after treatment, the improvement in MACI over microfracture in the co-primary endpoint of KOOS pain and function was maintained and was clinically and statistically significant ( P = .022). Improvements in activities of daily living remained statistically significantly better ( P = .007) in MACI patients, with quality of life and other symptoms remaining numerically higher in MACI patients but losing statistical significance relative to the results of the SUMMIT 2-year analysis. Magnetic resonance imaging (MRI) evaluation of structural repair was performed in 120 patients at year 5. As in the 2-year SUMMIT (MACI00206) results, the MRI evaluation showed improvement in defect filling for both treatments; however, no statistically significant differences were noted between treatment groups. Conclusion: Symptomatic cartilage knee defects 3 cm2 or larger treated with MACI were clinically and statistically significantly improved at 5 years compared with microfracture treatment. No remarkable adverse events or safety issues were noted in this heterogeneous patient population.

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Qianqian Lei ◽  
Hailong Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals Effect of Intradermal Thumbtack Needle for Functional Constipation: Study Protocol for a Real- World Clinical Trial

2021 ◽  
Author(s):  
WenQian Zhao ◽  
Ying Xu ◽  
Jingjing Liao ◽  
Ji Li ◽  
Li Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Real World ◽  
Functional Constipation ◽  
Assessment Tools ◽  
Life Questionnaire ◽  
Self Rating ◽  
Bowel Movements

Abstract Background: Many high-quality clinical trials have proved the efficacy of acupuncture in the improving frequency of spontaneous bowel movements, stool characteristics, and et cetera of Functional Constipation (FC) [1]. However, the high requirement of time make many patients unable to attend, this clinical trial will demonstrate the efficacy of intradermal thumbtack needle in ameliorate spontaneous bowel movement of FC.Methods: This multi-center real world clinical trial is performed involving 482 FC patients. All patients are randomly allocated into 2 group, which are group A to receive intradermal thumbtack needle twice a week for 4 weeks (intervention group n=241) or group B to take oral administration of mosapride 3 times a day for 4 weeks (control group n=241). This trial includes a 4-week treatment period and a 4-week follow-up period. The primary outcome is the number of completely spontaneous defecation per week, we use Weekly CSBMs analyze the frequency of spontaneous defecation per week during treatment and follow-up period to compared with the baseline. The secondary outcomes include FC patients’ stool consistence, gastrointestinal or anorectal symptoms, quality of life, anxiety and depression levels during treatment and follow-up period and efficacy expectations. The relevant assessment tools include: Bristol tool Form Scale (BSFS), Cleveland Constipation Score (CCS), Patient Assessment of Constipation Quality of Life Questionnaire(PAC－QOL), Self-rating Anxiety Scale (SAS) , Self-rating Depression Scale (SDS) and Efficacy Expectancy Scale. At the end, the scales filled by patients and researchers will be entered by data administrator, all the outcome assessments will be performed by independent outcome assessors and will be analyzed by professional statisticians with SPSS 25.0 software.Discussion: We hypothesize that intradermal needle is better than or equal to positive drugs in the improving frequency of spontaneous bowel movements, stool characteristics，and et cetera of FC patients . The results of this trial will provide us with a clinical basis for the application of intradermal needles in the treatment of FC.Trial registration: Chinese Clinical Trial Registry, ChinCTR2100043684.Registered on 26 February 2021.

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Yinan QIN ◽  
Qianqian Lei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background: There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.Methods: Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of the treatment period, and a 12-weeks of the follow-up period. During the 3-weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.Discussion: The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals Baidu Jieduan Granule in the Treatment of Coronavirus Disease-2019 (COVID-19): Study Protocol for an Open-Label Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Randomized Controlled ◽  
Epidemic Diseases

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan Granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan Granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan Granule in treatment of severe COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulder: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Yinan QIN ◽  
Qianqian Lei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background: There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.Methods: Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of the treatment period, and a 12-weeks of the follow-up period. During the 3-weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.Discussion: The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fang-Ting Yu ◽  
Di-He Long ◽  
Guang-Xia Shi ◽  
Li-Qiong Wang ◽  
Jian-Feng Tu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Common Adverse Effect ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Patient Assessment ◽  
Randomized Controlled ◽  
Bowel Movements

Abstract Background Constipation is known as a common adverse effect of antipsychotics. Advice for its management remains inadequate. This study is designed to investigate the efficacy and safety of electro-acupuncture (EA) for antipsychotic-related constipation. Methods This is a single-centric, parallel-group, randomized controlled trial with blinded participants, outcome assessor, and statistician. One hundred twelve participants will be randomly assigned into the EA group or sham acupuncture (SA) group in a 1:1 ratio. The study will last for 22 weeks for each participant, including a 2-week baseline assessment period, an 8-week treatment period, and a follow-up for 12 weeks. The primary outcome is the change of mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8 from baseline. Secondary outcomes include the change from baseline of mean weekly CSBMs during the follow-up period, mean weekly spontaneous bowel movements (SBMs), overall CSBM response rate, scores on Bristol Stool Form Scale (BSFS), straining level, Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of life questionnaire (PAC-QOL), and Brief Psychiatric Rating Scale (BPRS). Adverse events and medicine use will be recorded as well. Discussion The study is designed based on a rigorous methodology to evaluate the efficacy and safety of EA for antipsychotic-related constipation. The finding will be published in peer-reviewed journals as reliable evidence. Trial registration ClinicalTrials.gov ChiCTR2000032582. Registered May 3, 2020, with the Chinese Clinical Trial Registry.

Sign in / Sign up

Export Citation Format

Share Document